G8 Briefing on Health Issues
Background Briefing by a Senior Administration Official on Health Issues
International Media Center
Savannah, Georgia

11:00 A.M. EDT

SENIOR ADMINISTRATION OFFICIAL: Thank you very much. Im going to
take this opportunity now to give you a briefing on some of the G8
Summit health issues, but also to provide a little background that led
up into these initiatives that are now being discussed and implemented
vis--vis decision-making here at the G8 Summit. Its fundamentally
around the issue of HIV/AIDS, but I will, towards the end of my formal
presentation, before I take questions, also talk a little bit about the
initiatives on the eradication of polio.

Starting off with HIV/AIDS, there are a number of elements that are
involved regarding the treatment, care and ultimately prevention and
development of an HIV vaccine. The burden of HIV/AIDS is now well
known to most people who are informed a bit about the terrible health
crisis thats faced globally.

There are about 40 million people living with HIV, about two-thirds
of which are in the developing world of sub-Saharan Africa; about 95
percent are in individual countries that have low or middle income.

If you look at the numbers as shown on this particular PowerPoint,
as are mentioned the range is in between 36 million and 46 million,
with five million new infections in 2003, and three million deaths due
to HIV/AIDS. Those are really astounding numbers that have surpassed
in their magnitude what had been projected years ago in which some
people said that the projections were over-inflated. Were seeing now,
in fact, that theyre not.

As I mentioned just a moment ago, 95 percent of these individuals
are in low and middle income countries, and about 2,000 new infections
per day are in children under the age of 15 years, with a total of
14,000 new HIV infections globally daily in 2003. And, again, if you
look at the demography of that, about 12,000 of these 14,000 are in
young people age 15 to 49, and 50 percent of them are women. So this
is a problem of extraordinary magnitude.

One of the great scientific and public health triumphs in the
developed world has been the development of what we call Highly Active
Antiretroviral Therapy to treat directly HIV infection, which has
really transformed the life expectancy and the ability to lead normal
lives of people with HIV infection in the developed world. It is very
clear that this has markedly transformed death rates and morbidity.

This is a list -- and you dont need to worry about the list -- I
just show it to show you the magnitude of the accomplishment of the 22
now antiretroviral drugs, or anti-HIV drugs that have been approved by
the FDA and that have been available, again mostly in the developed
world and only recently now is there availability through a number of
programs that Ill very briefly outline for you in the developing
countries.

This is an important slide, because it shows you the disparity in
availability of coverage of adults with antiretroviral therapy. As you
can see, in the Americas, for example, 84 percent of the as-estimated
needed -- 250,000 people who need antiretrovirals are getting it,
210,000. In Europe its less so.

But look at Africa, which is what we will focus on for the next
couple of minutes. Only about two percent of those individuals have
gotten antiretroviral drugs in 2003, and thats something that obviously
is a main focus of how were going to change that through a number of
programs.

If you look in the United States as a prototype of the success, you
see on this slide that the newly-diagnosed cases in the red triangles
and the deaths in the blue diamonds have dramatically gone down in the
mid-90s when triple-combination antiretroviral drugs were available,
the circles, the blue circles that continue to go up in 2002 are due to
the fact and thats people living with AIDS is that there are new
infections in the United States, about 40,000 per year. So as the
deaths go down and the newly diagnosed cases go down, the people living
with HIV go up.

This is a very important advance that has been available in
developed nations such as the United States, Canada and Australia,
Western Europe, et cetera. If you look, then, at what the response to
that and this is a picture that we took in Durban, South Africa in
July of 2000, in which the same sort of community activism that asked
why not have drugs available for people in developing nations such as
in South Africa, Uganda, Kenya and other countries that are suffering
terribly, brought the first focus on the fact that the stumbling blocks
were what we called lack of infrastructure and the very high cost of
the drugs.

But what happened over a few years is that the cost of the drugs
remarkably came down and we began to examine whether existing
infrastructure would be amenable to the actual distribution and
availability of drugs to people in developing countries; things that
were in some respects, thought to be a foregone conclusion that it
could not happen.

Well, in fact, President Bush, in the spring of 2002, sent
Secretary Tommy Thompson of the Department of Health and Human Services
with myself and a number of other individuals on a mission to southern
Africa to a few countries to take a look at some of these questions of
feasibility of what we as the United States could do, and globally what
the world could do, and we came back and reported to the President that
there were a number of opportunities that he was very interested in.

He immediately initiated, back in June of 02, the Presidents
program on mother-to-child transmission, a $500-million program. But
at the same time as he initiated that, he asked me and other members in
the Department of Health and Human Service and his White House staff of
what can we do even more than a mother-to-child transmission. And what
about other areas in which we can take a very aggressive proactive
approach with HIV/AIDS.

And that led to what was announced in the State of the Union
Address in January of 03 when President Bush announced the Emergency
Plan for AIDS Relief, which I believe some of you, if not many of you,
are familiar with, which is a $15-billion program over five years that
is aimed at, engaged at preventing 7 million new infections, treating 2
million HIV infected people, and caring for 10 million HIV infected
people, orphans and other vulnerable children.

This is a program which is the largest single-directed public
health endeavor literally in the history of the United States with that
much money -- $15 billion over five years. The program, if you examine
some of the details of it briefly, is $9 billion to new programs in 14
countries, 12 in sub-Saharan Africa and two in the Caribbean, with a
15th country soon to be added shortly, and this now is under the
auspices of Ambassador Tobias of what we call the PEPFA program, the
Presidents Emergency Plan for AIDS Relief, $5 billion to approximately
100 nations, and our bilateral programs that are already going on, and
$1 billion over five years for the global fund. So theres going to be
$10 billion of new money there.

And rather than do it in the way in which we would impose Western
standards, what we did was we embraced African individuals, people who
are in positions, health authorities, to look in Africa as to whether
or not this element of infrastructure is something that we could use
low-tech, already-existing and supplement it a bit, build it up a bit,
and try and do it the African way in which we can help them with a
supply of drugs, namely having central medical centers as they had in
Uganda. And when the President announced this in his State of the
Union Address, some of you may remember Dr. Peter Magenyi* was there in
Washington as part of the back and forth that we had when we were
putting the plan together and when the President was making his
decision to endorse it, and then to have primary and secondary
satellite organizations.

We went back to Africa to take a look at that, and this is a
picture that I took with one of the young women, a 21-year-old woman
who was part of the network that had gone on in Uganda in which were
standing in front of her motorcycle, and this is her in her motorcycle
taking us and were now about four and a half hours outside of Kampala,
literally in the bush. We stopped, got out of the jeeps and then went
in Land Rovers and she with her motorcycle, and this is the example of
one of the individuals in the villages who has been and now will be,
continue to be receiving drugs on the Presidents emergency program. So
it is something that is on the ground and working.

The actual roll-out of the Presidents emergency plan vis--vis the
appropriations that now in Fiscal 04 was in February of this year --
and this is a slide of Secretary Thompson together with Secretary
Powell and Randy Tobias of the Coordinators Office, as well as the
internuncios of USAID.

Already, the disbursement of funds has now begun, and in fact, as
of the last tally, which was just a short time ago when we checked with
Tobiass office, there have been about $340-plus million that have been
disbursed by the Office of the U.S. Global AIDS coordinator. So the
program is already launched and the money is being disbursed.

Were doing it through, as part of what we call track one our
Catholic Relief Services, the Elizabeth Glaser Pediatric AIDS
Foundation, Harvard School of Public Health and the Mailman School of
Public Health who have in-country facilities there for the disbursal of
that, and then were going to, in the second phase of it, make sure we
get to the even secondary and tertiary.

What will this disbursement of funds do? The first round of funds,
we plan to have an additional 50,000 people in sub-Saharan Africa and
the Caribbean who are going to be receiving antiviral therapy, and
within days of that disbursement that I mentioned, resources were put
to use, for example, in eastern Uganda to deliver antiviral drugs to
families in their homes by motor scooter. And thats why I showed you
that picture of that young woman who was actually going into the bush
delivering. And then that was in Uganda.

And within a couple of weeks of that disbursement, the first people
in a slum in Kampala receive antiviral therapy through a faith-based
center, and within a few weeks adults and children in rural Kenya and
then now of the 21 antiretroviral programs funded, 19 of them have
finalized their plans and drugs are being ordered for multiple sites.
So this is a program thats working.

Also, of importance and Im telling you this as a background,
because this leads up to another phase of whats going here at the G8
theres the Global Fund for AIDS, Tuberculosis and Malaria that were
familiar with, which is a partnership between governments and civil
society, the private sector, affected communities to increase
dramatically the resources to fight these three very important
diseases.

Dr. Richard Feachem is the Executive Director and Tommy Thompson,
Secretary of HHS, is the Board Chairman.

This slide here shows that of the $5.3 billion that has been
committed to the global fund and thats the amount of commitments that
Im going to show you commitments, contributions and disbursements, and
thats where sometimes the numbers get confusing the commitment is over
$5 billion. The United States has committed $1.96 billion, or about 37
percent of that total. The contributions is $2.549 billion and again,
of which the United States you see there are other countries that are
very actively involved there. So this is a global effort, to be sure,
with a number of countries in Europe, Japan, Italy, et cetera, Canada
and others who have been involved in this $2.549 billion contribution,
and the disbursements now by region, as shown on this particular slide,
is about $348 million thus far. So we have a number of programs doing
things that were thought to be impossible.

Now, again, as the same way that President Bush told us after the
mother-to-child transmission that we need to go further and get adults
treated -- and thats why you had the $15-billion Presidents Emergency
Plan -- at the same time as we were doing that, he asked, can we do
something about prevention and vaccine development. And thats really
quite problematic, because vaccine is a very difficult, from both the
scientific standpoint and the idea about coordinating with people who
are involved.

So clearly, its a critical element of the effective control of HIV
globally, and it is clearly, at least in my experience at The National
Institutes of Health developing a number of vaccines, its certainly the
most important and difficult scientific challenge for reasons of the
very special nature of the HIV virus. The United States has invested
in the science and in the logistics of clinical trial networks. In 04,
about NIH, about $467 million if you add the Department of Defense,
its $488 million in 04 for HIV vaccine development. And we project
that in 05, it will be $533 million. Thats a substantial, vast
majority of all the money thats spent globally for HIV vaccine
development.

These and you dont need to know these these are just shown to you
as a spectrum of the number of vaccine strategies that are being
pursued. You have with vaccine a pipeline of products that go in, and
you have the clinical trials that need to be done. There have been a
number of clinical trials of products that have gone from pre-clinical
in animals into humans for safety, and then looking towards going to
what we call phase II and then ultimately phase III efficacy trials.

The problem has been is that there is not a lot of activity over
the past couple of years of things that have actually gone into the
efficacy trials, because although the candidates may seem promising in
their early phase, we actually need to have a global coordinated effort
to take a look at that, so that if the people in different countries do
different things, the information is easily transferable.

And with that in mind, we have, for example, a number of networks
that the United States government supports, either through the DOD, the
CDC or The National Institutes of Health. So we have the availability
of that, but we wanted to see if we can do something that will be in a
much more coordinated fashion.

One of the ways that one can do this, for example, is on the NIH
campus in Bethesda we have a vaccine research center, which does
everything from the basic research up through and including the
clinical trials, a critical mass of intellectual capital as well as
facilities. And this is a model thats working really very well.

Well, a year ago this June, in 03, a group of scientists got
together and we published a paper in science called The Need For A
Global HIV Vaccine Enterprise, and what we meant by that enterprise
and this was scientific-driven, this was a group of scientists that got
together was the possibility of doing things in a coordinated way and
essentially have a virtual consortium to accelerate HIV vaccine
development by things like coordinating, sharing information and
collaborating globally.

We met and these are an international group of scientists, these
are not just scientists from the United States, despite the fact that
most of the resources would come from the United States -- this was
input from a large group of scientists, we met at Airlie House in
Virginia, right outside of Washington, and we thought about the
possibility of accelerating the development of an HIV vaccine by
forming this alliance of multiple independent entities that are really
joined by what we call moral commitment to participate in the execution
of a global strategic plan.

We put together a group of individuals who formed working groups to
look at things like vaccine development, product development,
manufacturing, having laboratory standardization so we all agree upon
the kinds of things were going to measure. We being the global
scientific community. What about regulatory aspects or what have you.

There were about 150 scientists that were working on that from 12
separate countries. Again, this is something that attracted the
attention of the administration and of President Bush who asked the
staff to put together a proposal for the G8 for a vaccine enterprise.
And let me explain what it is, because the strategic plan that is going
to be called for by the G8 here in Sea Island will be calling for the
enterprise which is the development of a strategic plan thats a global
strategic plan that would do several things: encourage the development
of coordinated global HIV vaccine development centers that are very
similar to the center that we have on the NIH campus, but to have it
globally throughout the world.

It could be a virtual center of bringing people together who are
intellectually bound, not necessarily in the same building, or actually
a center that is a center similar to what we have at the NIH, to
stimulate the capability of dedicating vaccine-manufacturing capacity,
because the vaccine industry is very fragile. Were not sure whether
or not theyre going to be able to handle, if we have some red-hot
candidates who need to have scale-up manufacturing to do phase I, II
and III clinical trials.

We want to be able to have standardized laboratories so that if
someone does something in England or Japan or in Africa that its usable
because were looking at the same thing. How about expanding the
international clinical trial system. I showed you that map of what we
have in the United States with the U.S. government and globally in
Africa, Asia and other countries, what about bringing together in a
network the very good clinical trials networks that other countries
have.

How about harmonizing regulatory authority so that if someone does
a trial in the United States, it can be usable, the data in the
regulatory capacity in Europe and vice-versa, and in Africa versus
Canada and what about getting greater encouragement or engagement by
scientists from developing nations. And thats the strategic plan that
was put forth by the President that is being embraced here in Sea
Island by the G8. And I think itll be a very important way of bringing
together in that commitment to that strategic plan and accelerate our
ability to develop a vaccine.

And on this slide, we show, again, the fundamental things that we
spoke about, that the President spoke to us about a few years ago when
we were talking about what kind of initiative we could have with HIV
it involves everything. The treatment that we spoke about in the PEPFA
and the global fund, prevention would not only the kinds of prevention
programs that are going on, but also vaccine development and ultimately
care.

I just want to spend the last couple of minutes of the formal
discussion just on some background on the global efforts to eradicate
polio. Many of you are aware that this has been, globally, a very
serious, important problem before the development of a safe and
effective polio vaccine in 1955, when the Salk vaccine, the inactivated
polio was used and in 1963 the live attenuated Sabin vaccine was used.
The last wild poliovirus in the United States was in 79.

In 1988, the World Health Assembly launched what we referred to as
the PEI, or the Global Polio Eradication Initiative, and in 1994, the
Western Hemisphere was certified to be polio-free. But the goal of the
Eradication Initiative has been now, by 2005, to have the total global
eradication of polio the same way that we totally we the scientific
global community and public health community eradicated smallpox
decades ago.

The United States efforts since 1988 to 2005 towards this global
initiative in which many countries have been involved as shown on this
slide where there was a pledge of contribution of almost $1 billion,
$981 million, including $180 million for 04 and 05, also was a
participation in an aggressive way with other countries in the goal to
eradicate polio by 05, by bilateral assistance and pledging and dealing
with other countries.

This is a pie chart showing the global efforts, and there are many,
many groups, both private and governmental, that are involved in
addition to the United States. Theres Rotary International, theres the
World Bank. Theres you can see in the light blue the U.K. and a
number of countries Germany, Canada, France, et cetera, et cetera so
it truly is a global program.

There has been a funding gap, which Ill get to in a second, in that
in 04 and 05 it was felt that there was a shortfall because there was
an unexpected and unfortunate exacerbation of the polio spread when we
were on a track looking like we were heading towards the eradication,
the 04 gap has been filled, and we hope with the G8 now to have the
commitments to fill the 05 gap and essentially have enough money to
continue the vaccinations.

The Eradication Initiative, there are many achievements and there
are challenges. The achievements are that there were 125 countries
that had endemic polio in 1988. Its now down to six, as I showed in
the previous PowerPoint. The 2004 funding gap has been closed through
efforts of a number of countries, including the United States.

The challenges are the six endemic countries that remain. I showed
you on that other slide Niger, Nigeria; Egypt, India and Afghanistan as
well as the nine countries to which it spread in sub-Saharan Africa
apparently from Nigeria. So there was a setback, but there is a true
concerted effort now to try and overcome this latest challenge and to
fill that funding gap so that the immunizations can continue.

This is that map of the 1988 vs. 2004. An extraordinary amount of
progress has been made, but this is something thats truly a
deliverable that if we can get everyone involved here in the G8, and I
believe they will be, to make the commitment to not only close the gap,
but to keep that gap closed.

And the Eradication Initiative hopefully will turn these challenges
into achievements, as I mentioned, by continual support of the six
polio-endemic countries, and urging those governments to continue their
commitment towards mass immunization, and on the part of the G8 and
other developed nations of the world to have these donors and
organizations to continue to support and encourage these countries in
polio eradication efforts, which we believe can be successful.

So Ill stop there and Ill be happy to take some questions.

Q Doctor, as you know, theres been some controversy over the
WHOs prequalification project process, and whether those drugs meet FDA
standards. Has there been any discussion of whether the U.S. is
willing to accept the WHO standards?

SENIOR ADMINISTRATION OFFICIAL: Yes. Again, we have to remember
thats a very good question theyre referring to a fixed-dose
combination of three drugs that are used in a single pill that the WHO
has prequalified. The WHO is not a regulatory agency. We have a great
deal of respect for what they have done, but recently, literally weeks
ago, the FDA has come out with guidelines that I believe is going to
get us around that issue, and that is to markedly expedite the
evaluation of drugs that are either drugs that the brand companies will
put into a fixed-dose combination or in what we call a co-packaging of
three separate versus one pill. And given the fact that theres an
enormous amount of data on those individual drugs, that they can get a
rapid, within six-week, full approval to be used in the United States
or in developing countries.

Theres a tentative approval component of that, which means, for
example, the companies that are making the fixed-dose combination, they
can get, if they pass certain fundamental issues that we think are very
important like are these chemically equivalent, do they have
pharmacokinetics, or is the ability of the drug to get into the body
and circulate well based on that and other clinical data, they can get
tentative approval which means if they go through the steps which the
FDA has promised they will expedite and depending upon what the
product is, that could be months or what have you to expedite that so
that if it gets tentative approval it can be used in countries, and
even purchased by the PEPFA program, provided it doesnt violate the
individual countrys patent rules. But, example, if a country has
compulsory licensure and is in an emergency situation, they will be
able to use that. So I think its been a major breakthrough on the part
of the FDA with their recent guidance to really be able to expe

Q Just a quick follow-up. Do you know how that will affect
cost?

SENIOR ADMINISTRATION OFFICIAL: Excuse me?

Q Do you know how that would affect the cost of the drugs?

SENIOR ADMINISTRATION OFFICIAL: Well, again, the cost of the
drugs the drugs in question -- right now the drugs have remarkably
gone down. The brand companies themselves are selling it remarkably
lower. We can do it with the drugs that are already available for
several hundreds of dollars -- $500 or what have you. Youve heard or
read about the fixed-dose combination, which they say can go down to
even less than $200 thats not totally accurate because if you talk
about the delivery costs of getting it to the people, it probably is a
bit higher than that. But, hopefully, depending upon the lowering of
prices by the brand name and the ability of those who are making
copies not generics copies, which is what the fixed-dose combination
is, that if they can get it down to several hundred dollars, I think
its going to be quite good.

But remember, one point that I do want to make that sometimes gets
misconstrued is that the disbursal of funds and the delivery of drugs
through the Presidents program is going on now anyway. So it isnt as
if people are not getting drugs because of this apparent dichotomy of
acceptance of prequalification or not; thats being worked out through
the FDA guidance. But the people are still getting the drugs through
the PEPFA program and through the global fund. So I know that
sometimes you read that, gee, people are not getting drugs because of
that, thats really not the case.

Q Can you comment any on the bioterrorism measures that were
expected to be discussed at the Summit?

SENIOR ADMINISTRATION OFFICIAL: The only thing I can comment is on biodefense issues -- of which, at the NIH, the part of the Department
of Health and Human Services were responsible for -- certainly,
President Bush has put an enormous commitment into the development of
countermeasures in biodefense.

If you look at the amount of commitment just to the National
Institutes of Health alone from, for example, fiscal 02 to 03, it was a
$1.5-billion increase for the development of countermeasures such as
new vaccines for smallpox, vaccines for Ebola, anthrax, botulism
antitoxins, some drugs or what have you. So, the health issue
vis-a-vis what were trying to do to develop appropriate countermeasures
is one of the major health research initiatives that has occurred in
years. And in fact, it is probably the largest single infusion of
dollars into biomedical research for any individual specific issue that
we have, literally, in the history of the NIH. So, its a substantial
commitment on the part of the administration.

Q Two questions for you. I think you said the U.S.
government spending for HIV vaccine research is about $488 million this
year?

SENIOR ADMINISTRATION OFFICIAL: Yes, including the DOD, right.

Q Maybe I missed this, but what is the global total for
research spending and will there be more money needed to accomplish the
goals you laid out in the G8 strategic plan for the vaccine
coordination.

My second question is also to do with money. I believe the
European Union committed $70 million for polio earlier this week

SENIOR ADMINISTRATION OFFICIAL: Right.

Q -- and I thought there was some sort of a gap of $100
million.

SENIOR ADMINISTRATION OFFICIAL: Right.

Q Right.

Q -- You mentioned $23 million maybe you can clear up those
figures.

SENIOR ADMINISTRATION OFFICIAL: No, no, thats a very good point.
Ill get to that in a second. Let me answer your first one.

We have tried and organizations like IAVI the International Aids
Vaccine Initiative have tried to get their arms around just what the
global commitment is. We have a pretty good idea of what other
countries are giving, of what other NGOs are giving. We dont have a
completely accurate idea about what individual pharmaceutical companies
are putting in, because its very difficult to get precise data from
them. But we have a pretty good idea, looking at what the relative
commitment that they have for vaccines in general.

The ballpark estimate is that the total, including the U.S.
Government, is somewhere between $650 million and $700 million at a
high. So if you look at 04 in which we put $488 million and 05 in
which will be $533 million, we have clearly the United States the
vast majority of the resources that are going into the vaccine research
endeavor. We hope that the alliance, which is really a virtual
consortium of individuals, will stimulate not only resources from NGOs
and other countries to join us in this effort, but we will also be able
and well hear that this is off the record -- that there will be, in
addition to what were doing some money that will be put in to have yet
again another center that would not be at the NIH, but that would be
funded through the standard mechanisms of the peer reviewed process to
try and get the ball rolling in that regard.

But if you look at the amount of resources, we would like to see
the other countries not only join us in this endorsement of a strategic
plan so we could synergize together, but also countries that are trying
to align their own resources and say, what can we do in HIV thats not a
silo thats gone up but thats part of the big plan. Thats really the
fundamental philosophy of the G8 Initiative, is to get an agreed-upon
strategic plan.

The point that you make about the gap you are absolutely correct.
The amount of money clearly closed part of the gap. It varies because
of its still a moving dynamic target. The gap is anywhere between $20
million, $30 million, and even as high as $100 million or more its
very difficult to pin down what that is, and thats the reason why, in
the proposal of polio that the G8 has endorsed that was put before the
group by President Bush was that, lets do what it takes to close the
gap, whatever the gap is. If its $30 million, lets close it, if its
$100 million, lets close it.

Q Just a quick follow-up. Is that $23 million you mentioned
after the EU commitment?

SENIOR ADMINISTRATION OFFICIAL: No, thats before no, that was
after the EU commitment. The EU commitment took care of 04.

Q Okay, so the $23 million is remaining after the EU
commitment?

SENIOR ADMINISTRATION OFFICIAL: Yes, the $23 million is the 05.

Q Okay.

SENIOR ADMINISTRATION OFFICIAL: And it might be more than that,
youre quite correct depending upon what this moving target is.
Because remember, we have 6 countries in which its endemic, and we have
9 countries to which it has spread from one of those countries.

Q Okay. And you just mentioned, off the record, a second,
perhaps, vaccine center. Did you mean in the U.S. or somewhere else?

SENIOR ADMINISTRATION OFFICIAL: It will be going through the peer
review system, and most likely it will be certainly not on the NIH
campus, it will be something that likely would be funded. And youll
hear more about that tomorrow.

Q I just wanted some clarification on the Global Strategic
Plan. Does this mean that the G8 are going to put out a declaration
of a specific timeframe on how to coordinate these global efforts to
find a vaccine?

SENIOR ADMINISTRATION OFFICIAL: Yes. What will happen is that the
G8 has embraced this concept of an enterprise. And I mentioned theres
some background for the this is scientist-driven, as I mentioned that
was that meeting we had the paper we wrote and the meeting we had last
year.

What were calling for and what the G8 will be calling for will be
an endorsement and an embracing of this strategic plan so that sometime
within a period of months that the group will meet that has already
been involved in this enterprise and report on a strategic plan that
has been developed that is science-driven, and then, hopefully, each
year as the presidency goes, like, for example, this year at the United
States to the U.K. that once a year we will report to the G8 country
that has the presidency about A, the strategic plan and B, how we are,
in fact, endorsing and implementing this synergy and collaboration that
will ultimately get us to that goal.

Q Yes, this question is concerning the prevention of the
spread of AIDS. I just wanted to know what does education play what
role does that play in the prevention and how much is being spent for
education in relation to the vaccine research spending?

SENIOR ADMINISTRATION OFFICIAL: A considerable about. In fact, if
you look at prevention and look at the Presidents program, for example
and there are other prevention issues that are going on in the United
States and globally. If you look at the United States, theres a
significant amount of money in prevention. In fact, vaccine is just a
part of the major prevention effort.

About less than 20 percent of the total NIH budget is in vaccine
-- in my institute its about 23 percent. We have a modest amount at
least equivalent to that in prevention. The CDC, the Centers for
Disease Control and Prevention, has a substantial amount. I dont have
the figure right on my fingertip what it is in prevention, but if you
look at the PEPFA program, the Presidents program, thats in the
international global for the 14 countries -- again, I dont want to
restrict that to relative proportion, but originally, in the design of
this, there was at least 20 percent of that that was going to various
forms of prevention, ranging from education, behavioral modification,
abstinence programs, condom distribution the whole gamut of prevention
efforts is an important part of the Presidents program.

Q Apart from Nigeria, what would the other countries be where
polio is still endemic? I missed that.

SENIOR ADMINISTRATION OFFICIAL: Actually, Ill get it for you so
you can have it here. Its Niger, Nigeria; India, Egypt, Afghanistan
and Pakistan. I have them let me see if I can get them for you.

Q No, thats fine.

SENIOR ADMINISTRATION OFFICIAL: Well, Ill leave it up on the
screen for you so you dont have to rush in your writing.

Q Thank you.

SENIOR ADMINISTRATION OFFICIAL: Its right there. And those are
the countries with the outbreaks through importation its right on the
lower left side of the slide.

Q I was wondering if you could clarify something for me. You
talked about the global fund and the U.S. contribution and suggested
the U.S. contribution was far larger than any other. NGO has been
telling me that under President Bushs plan the U.S. pledge for 05 is
actually a 64 percent reduction on what was spent before. I was
wondering if you could clarify that.

SENIOR ADMINISTRATION OFFICIAL: Yes. I really would be happy to
clarify that because I think thats a somewhat of a misunderstanding
about what the global fund, vis-a-vis, the Presidents program.

Prior to the Presidents Emergency Plan for AIDS Relief, there was a
considerable amount of money and I could show you-- Ill put this slide
back up on what the commitment to the global fund is. When the
President made the commitment to spend $15 billion on a bilateral based
program which is substantial; I mean, that is just the boldest,
largest initiative that one has in HIV research globally, ever, by far
-- part of that program, as I mentioned, was a program that would be
the $15-billion program, including $1 billion over 5 years to go into
the global fund.

So, you know, people say, were cutting the global fund were
putting $200 million a year for 5 years it looks like it is a cut but
it really isnt. Its adding on to the totality. So if you look at what
the United States contribution to the global AIDS effort, its the
global fund, but an enormous amount on the Presidents Emergency Plan
for AIDS Relief, which includes a contribution to the global fund. So
rather than looking at us cutting anything, youre adding $15 billion on
to it. Which, again, somehow gets misconstrued when people talk about
the balance between global fund versus the Presidents program

Q You know when youre talking about the search for a vaccine
youre emphasizing the need for international global cooperation and
coordination. However, in terms of actually caring and treating for
AIDS, the emphasis now seems to be on the bilateral approach as opposed
to the global fund. Is that the right message Im getting?

SENIOR ADMINISTRATION OFFICIAL: Im sorry, Im not sure I understand
what you were saying.

Q The $15 billion announced by the President is on bilateral
programs U.S. sponsored

SENIOR ADMINISTRATION OFFICIAL: Right.

Q -- with the government as opposed to going for an
international approach a coordinated approach.

SENIOR ADMINISTRATION OFFICIAL: Right.

Q -- whereas some critics would argue that African countries
would need to know that there is a one-stop shop for them to go to, to
get funding for these antiretroviral programs

SENIOR ADMINISTRATION OFFICIAL: Yes

Q -- as opposed to having to look for individual donors to
contribute bits and pieces. So Im just saying, wouldnt your view be
that in terms of actually fighting and caring for AIDS, that the global
approach and the global fund would be the better way to go?

SENIOR ADMINISTRATION OFFICIAL: I dont think its appropriate to
make a judgment as what is the better way to go. I think I like to
look at it as programs that ultimately, as things start to accelerate
in the disbursal of the funds, in the distribution of the drugs, become
almost seamless between the two, as opposed to one thats opposed to the
other. I dont look at it that way. I look at is as multiple ways to
get to the goal that we all want to get to.

Theres way that you put money into a pot and it gets distributed
and theres a way that where a bilateral arrangement can be very
efficient. I might point out to you I believe the global fund has
done an excellent job, the President is committed to the global fund,
Tommy Thompson is the chair of the global fund theyve disbursed about
$348 million. The PEPFA program has disbursed already $342 million so
theyre both doing a very good job and I think its going to get better
and better. So rather than look at as if theres a going in the
direction of downplaying a particular approach, I look at more of the
approaches coming together. And I think thats going to work.